Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors

Breast Cancer Clinical Trial

Official title:

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590949
• Other study ID #: 22-280
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: October 18, 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Monica Fornier, MD
• Phone: 646-888-4563
• Email: fornierm[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 18, 2024
• Est. primary completion date: October 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with confirmed diagnosis of breast cancer

• Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment

• Received at least 2 doses of denosumab and then discontinued therapy

• Discontinued AI prior to or within 6 months of last denosumab injection

• Patients must be 18 years of age or olde

Exclusion Criteria:

• Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;

• Patients with history of insufficiency fracture.

• Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab

• Patients on chronic low-dose glucosteroids.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Physical Evaluation
Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed).

Diagnostic Test:
• Dual-energy X-ray absorptiometry scans
Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
• Trabecular Bone Score
TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum carboxy-terminal collagen crosslinks (CTX)	Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX)	12 months
Primary	Change in bone specific alkaline phosphatase (ALK)	Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK)	12 months

External Links

•   Memorial Sloan Kettering Cancer Center